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Rifaximin

Phase 2

Crohn's Disease | Small molecule | Gastrointestinal |Bausch + Lomb Corporation|Last Updated: Dec 9, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Rifaximin · 1 trial · 1 indication

Phase 2 1
NCT00603616Induction of Clinical Response Using Rifaximin in Crohn's DiseaseCrohn's Disease
COMPLETED36 Analytics
PHASE2COMPLETED
Induction of Clinical Response Using Rifaximin in Crohn's Disease
Crohn's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the efficacy of rifaximin 550 mg bid compared to placebo in achieving clinical response in moderate to severe Crohn's Disease (CD) subjects as determined by a > 100 point decrease in the Crohn's Disease Activity Index (CDAI)
8 weeks

Secondary Endpoints

Evaluate the efficacy of rifaximin compared to placebo at inducing clinical remission in CD subjects
8 weeks
Evaluate the safety profile of rifaximin in subjects with active CD
16 weeks for those subjects who do not cross over, 32 weeks for those who do cross over
Evaluate the effect rifaximin has on the quality of life in subjects with CD compared to placebo
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATORPlacebo pills
2ACTIVE_COMPARATORRifaximin

Interventions

NameTypeDescription
Placebo ComparatorDRUGMatching oral placebo pills to be taken twice daily for a total of 8 weeks
RifaximinDRUGOral rifaximin 550mg to be taken twice daily for a total of 8 weeks
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female subjects, 18 to 80 years of age, inclusive, that can themselves provide written, informed consent and authorization of use of protected health information prior to any study-related procedures and who are, in the opinion of the investigator(s), likely to comply ...

Countries:United States
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Frequently asked questions about Rifaximin

What is Rifaximin used for in Crohn's Disease?

Rifaximin is an investigational small molecule being studied for the treatment of Crohn's Disease, a type of inflammatory bowel disease. It is being evaluated for its ability to induce clinical response in patients with this condition. The drug is currently in Phase 2 clinical development for this indication.

What does Rifaximin target?

Rifaximin is a small molecule antibiotic that works by inhibiting bacterial RNA synthesis. It targets the bacterial DNA-dependent RNA polymerase, thereby reducing intestinal bacterial overgrowth and inflammation. This mechanism is thought to contribute to its potential therapeutic effect in Crohn's Disease.

Who makes Rifaximin?

Rifaximin is being developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker symbol BLCO. The company is conducting clinical research to evaluate the drug's safety and efficacy for the treatment of Crohn's Disease.

What phase is Rifaximin in?

Rifaximin is in Phase 2 clinical development for Crohn's Disease. It is an investigational drug, meaning it has not been approved by regulatory authorities for this use. The drug is being studied in a clinical trial to assess its ability to induce clinical response in patients.

What clinical trials is Rifaximin in?

Rifaximin has been studied in one completed Phase 2 clinical trial with the identifier NCT00603616, titled 'Induction of Clinical Response Using Rifaximin in Crohn's Disease.' This randomized, double-blind, placebo-controlled trial enrolled 36 participants in the United States and included biomarker-selected patients.

Is Rifaximin the same as Xifaxan?

Rifaximin is the generic name of the drug also known as Xifaxan. The drug is being investigated for Crohn's Disease, and it is important to note that while Xifaxan is an approved brand name for rifaximin in other indications, its use in Crohn's Disease remains investigational and is not yet approved.